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FDA has streamlined the Compassionate Access / Expanded Access policy paperwork; it now can be completed by physicians in 45 minutes.
Doctors still must first obtain a letter of authorization from that drug's manufacturer. Getting authorization from manufactures is the difficult part; drug companies might reject requests because they're worried about liability if the drug causes harm or they might consider the drug unsuited for a particular patient. If doctors are granted manufacturers' consent, they next submit the newly streamlined application to the FDA. The agency has approved 99 percent of the applications filed for the past six years, FDA figures show.
In streamlining the form so doctors can compete the paperwork more readily, the FDA has bolstered a larger movement to make experimental drugs more accessible. 29 states have "right to try" laws aimed at improving terminally ill patients' access to experimental treatments.
The NPR story from which the above info was summarized:
FDA Moves To Speed Access To Compassionate-Use Drugs
http://www.npr.org/sections/health-shots/2016/06/08/481147958/fda-moves-to- speed-access-to-compassionate-use-drugs
FDA info page and links for patients and physicians:
Expanded Access (Compassionate Use)
http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionate Use/default.htm
Wikipedia seems to have the most up to date info about which states have "right to try" laws - currently 29: Right-to-try Law
https://en.m.wikipedia.org/wiki/Right-to-try_law
Right To Try also has a FAQ about the laws:
http://righttotry.org/faq/
woodrow5....I look forward to your posts on trading breakdown as I find it interesting and informative. Thanks for sharing this with the board!
Greats news for that patient and agree with QOL improvement is important, appreciate your post!
Drilla and Bob thank you for your post on Q1 numbers! Looking very promising for Q2 and PetroRio considerably undervalued.
Agree with you 100%! News is going to hit and market does not see this coming!
I hope so as well as time is of the essence and just terrible patients are suffering daily from this dreadful disease. I agree on UCLA, combo trial and Dr. Liau who also was Jeannine Walston's neurosurgeon.
From Inspire message board....sad that this is going on for patients and families.
Great find and very encouraging words from Mr. Woodford!Thanks for sharing!
I had not seen this before (in bold)as I read this from their new web site www.intellectns.com and find it encouraging for ILNS.
It was as an FYI as some appreciate updates related to NWBO-
NWBO also has 4-5 clinics in UK involved in DCVax and immunotherapy for GBM and nice to see more funding in this battle against a dreadful cancer.
Cancer Research UK Awards £16M to 4 Centers Working to Better Treat Difficult Cancers
May 17, 2016 07:00 am | Charles Moore
http://immuno-oncologynews.com/2016/05/17/tackling-brain-tumours-understanding-immunotherapy-revealing-cancers-genetics-end-life-accelerating-progress-centres/?utm_source=IO+News&utm_campaign=585a7bd670-RSS_WEEKLY_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_f04c303b86-585a7bd670-71536809
Thanks Drilla! I am holding long term as well and appreciate your response. someone is dropping = to or < 100 shares to try and keep PPS down every time it make a move higher on small volume.
anyone watching the selling of 100 shares every time the PPS moves upward on low volume, they dump 100 shares to lower the PPS of HRTPY. Where is the trading volume on this stock? The stock is way undervalued based on current cash and market cap.
Where is this going in 2016? Drilla? Holding shares?
Turtle, I do not have blinders on and can see what is going on but I have to say your relentless rants about PPS decline are just nauseating. Funny thing is you never ranted about PPS when the PPS was climbing up to its high of $12.55 last July. I am just as frustrated as you and many longs on this board on PPS decline and continuous manipulation of the stock I wish I kept my discipline to take my cost basis off the table last August when it declined and shame on me for not doing it. I could own a lot more shares now had I done that.
I am one of the long time members of this board with my due diligence from the early days here NWBO was onto something big with dendritic cell immunotherapy and the goal line is getting close now. My cost basis in all my accounts is still about $3.43. I am waiting to see a bottom and pickup a bunch more to lower my cost basis just below a $2.00 a share.
No ill will to you and wish you good luck!
Well said Dok! Gets a bit nauseating with the same rants over and over.
TC, my close friend is a 28 year veteran in Federal Law enforcement criminal investigations who knows of Mr. Black and told me recently "if there has been any criminal activity related to NWBO stock manipulation, corruption, he is highly decorated CIA veteran will connect all of the dots if he is involved. We have many tools to use at our disposal as well as inter agency cooperation."
woodrow, I agree with you 100% on this! Great post!
beartrap, thanks for this post as I had forgotten you attended the last shareholders meeting and details you shared from your experience attending the meeting.
Why would Mr. Maza not PR this as this is a very interesting find? Thanks for sharing this find!
meant for it 5 months since Dec PR and now overdue from their projection of 90 days as noted in PR....
The investigation is overdue now 5 months since December 8, 2015 PR and as we see quite often NWBO missed their timeline for completion (at least 90 days) so it must be getting close. The other potential catalyst is the (3) different combination treatments with (3) different parties from their May 2nd Operations update. I would assume that still could take a while but no more than 90 days from May 2nd PR as I would expect the process was pretty far along before they made the announcement.
I may be wrong but those shares you reference were gifted o family as there was a an SEC filing for that back then.
Good point Doc on Woodford as I find it interesting with his 25M shares of NWBO, he has not sold a share, neither has Dennis Mehiel, nor Linda Powers, Les Goldman, Dr. Bosch, etc. Woodford and Mehiel are very smart investors and would have sold and moved on if they felt their investment was at risk.
I guess we will find out this month if NWBO does not come through with significant news, Combo partnerships with Direct or L, investigation complete with positive findings, regulatory update/approval or new funding at favorable terms, this stock will be driven much lower. I cannot see NWBO management letting this happen as they see what is going on with their stock price every day, painful!
NWBO Market Cap after yesterday's close is now $97M which is just absurd with a international Phase III brain cancer trial to complete in September 2016.
Anyone picking up shares in this sub dollar has huge upside if major PR( noted above) is out by end of the month. JMO
great explanation and one of the better posts today. Thanks for sharing!
Exactly.....
I am totally in the same page as you on your post! How can buy volume exceed sell volume and go down in price.
almost 150k shares trade in last 10 minutes of trading and price moved up $.02.
Here is summary:
1,125,936 at $.95 at 3:50PM
1,274,323 at $.97 at 4:00PM
Great point montanus!
Well said kabunushi! Ditto that!
That is what I thought, agree with you on this and thanks for posting!
Was this GSK trial done with ILNS Conjumab AMD program?
Over 730K shares today at $1.33 and a shade over 2 hours since opening bell!
Volume continuing 630k as of a few minutes ago
Nice volume today already over 400k shares traded!
Yes I saw that as well but Fidelity listing these dates in the past has been pretty accurate, so I just thought I would post as an FYI
NWBO Earnings Report Due Today May 9, 2016 according to my Fidelity Trading platform.
Very well said! Bravo, especially coming from a oncology physician!
We will see shortly I am sure and if I am wrong I will respond as such
I always appreciate your posts coming from a oncology physician. Thanks again for sharing with this board!
I agree with you on combo trails with (3) big pharma providing upfront multi-million dollar payment to NWBO and then additional payments on milestones being met in their trials. I can see (3) consecutive PR's over a week or two issued by NWBO and partners on their combo trials with DCVax with upfront dollars and milestones.
How would the market react if each of the (3) companies partnering with NWBO have upfront payments of $15-20M which is not out of the question in these deals.